A delivery system (50) for a detachable medical device (10) comprises a first helical wire (12) attached to the medical device, a second helical wire (18) attached to a deployment member (16) and a wire coil (30) which is arranged to interconnect the helical wires (12, 18). A pull on a release wire (32) at one end of the coil (30) detaches the coil from at least one of the helical wires whereby to detach the medical device (10) from the deployment member (16). In a modification a release coil (130) is arranged between concentric helical wires (112, 118).
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1. A delivery system for a detachable medical device, the system comprising the detachable medical device having a first release portion, a deployment member having a second release portion, and a releasing element comprising a wire coil having a proximal end and a pull release wire attached to the proximal end, wherein the first and second release portions each having a helical element having windings defining a respective helical wound path therebetween, the wire coil of the releasing element and the windings of the first and second release portions having substantially the same diameter and pitch, such that the wire coil of the releasing element engages both of the helical wound paths between the windings of the first and second release portions to hold the first and second release portions together, the releasing element being detachable from the first and second release portions by a pull on the release wire, the pull allowing the proximal end of the wire coil to move slightly radially inwardly and then axially in the proximal direction, whereby to detach the first and second release portions from each other.
12. An introducer system for an implantable medical device comprising an introducer device, a pusher member connected to the introducer device, and a handle movable relative to both the introducer device and the pusher member, a deployment member located distally of said pusher member and a medical device located distally of said deployment member, the medical device having a first release portion, the deployment member having a second release portion, and a releasing element which is arranged to interconnect the first and second release portions, the first and second release portions each having a helical element having windings defining a respective helical wound path therebetween and the releasing element comprising a wire coil having a proximal end, the wire coil engaging both of the helical wound paths between the windings of the first and second release portions to hold the first and second release portions together, the wire coil of the releasing element and the windings of the first and second release portions having substantially the same diameter and pitch, the releasing element being connected to said handle via a release wire, the arrangement being such that, upon a proximal movement of the handle relative to the rest of the introducer device, the releasing element is detachable from the first and second release portions, the proximal movement allowing the proximal end of the wire coil to move slightly radially inwardly and then axially in the proximal direction, whereby to detach the first and second release portions from each other.
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This application is related to and claims the benefit of priority to GB 1207619.6, filed on May 2, 2012 which is incorporated herein by reference in its entirety.
The present invention relates to an implant delivery system and in particular to a system for releasing implantable devices, such as coils, into blood vessels and body cavities such as aneurysms.
Various systems are known for releasing a coil after it has been advanced by an introducer system through the vasculature of a patient. For example, in US 2010/0268201 the implantable device is fixed to its delivery system by means of a looped tether. US 2008/0103585 discloses an example of a system in which a coil is released electrolytically.
In other systems, such as the Jackson system, coils are connected to a delivery wire by a wound junction. This screw connection is detached by rotating the wire by means of a handle. This can be inconvenient in that it requires the handle to be rotated many times.
Aspects of the present invention seek to provide an improved delivery system which permits a simple and rapid method of release.
Other aspects of the present invention seek to provide an improved delivery system permitting release of implants successively.
According to a first aspect of the present invention, there is provided a delivery system for a detachable medical device, the system comprising a first release portion on the medical device, a second release portion on a deployment member and a releasing element which is arranged to interconnect the first and second release portions, the first and second release portions each having an element defining a respective path of wound configuration and the releasing element comprising a wire coil which engages both of the wound paths to hold the release portions together, the wire coil having a pull release wire attached to one end thereof, the releasing element being detachable from at least one of the release portions by a pull on said release wire, whereby to detach the release portions from each other.
In one preferred embodiment, the release portions are substantially in alignment and each release portion comprises a respective helically wound wire with turns forming a hollow core, the wire coil of the releasing element having turns which engage with end turns of the wires of both the release portions.
As used herein, the term “wire” designates any suitable elongate element of metal, plastics or any other suitable material; it may have any suitable size and shape and may have a cross-section which is constant or which varies along its length and may be circular or non-circular, such as elliptical, square, rounded off square or polygonal.
The ends of the helically wound wires of the release portions may be in a substantially mutually abutting relationship.
In a modification the release portions are concentrically arranged helically wound wires, the wire coil of the releasing element having turns, the exterior side of which engage with the interior of turns of the outer wire and the interior side of which engage with the exterior of turns of the inner wire.
The wire forming the coil may have an elongate cross-section.
In preferred embodiments, the second release portion comprises a tubular part at the end of its wire remote from the first release portion, and the release wire extends through the tubular part.
The material of the wire of the releasing element is substantially softer than the material of the helical wires of the release portions.
In another modification the release portions are substantially in alignment and wherein each release portion comprises an externally threaded member, the wire coil of the releasing element having turns which engage with the external threads of both release portions. In this case, the release portions preferably have a uniform circular cross-section.
The wire coil may be of resilient material.
According to a second aspect of the present invention, there is provided an introducer system for an implantable medical device comprising an introducer device, a pusher member connected to the introducer device, and a handle movable relative to both the introducer device and the pusher member, a deployment member located distally of said pusher member and a medical device located distally of said deployment member, the medical device having a first release portion, the deployment member having a second release portion, and a releasing element which is arranged to interconnect the first and second release portions, the first and second release portions each having an element defining a respective path of wound configuration and the releasing element comprising a wire coil which engages both of the wound paths to hold the release portions together, the releasing element being connected to said handle via a release wire, the arrangement being such that, upon a proximal movement of the handle relative to the rest of the introducer device, the releasing element is detachable from at least one of the release portions whereby to detach the release portions from each other.
In preferred embodiments, the pusher member has an interior lumen and the release wire passes from the wire coil to the handle through said lumen.
The release wire is preferably integral with the wire coil.
Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, of which:
Referring to the drawings,
Coil 36 is of a resilient material such as nitinol or soft steel. To attach the wires 12, 18 to the coil 36, the wires can effectively be screwed in from opposite ends. The release members 10, 30, 16 are preferably manufactured and supplied in this pre-assembled form, in a sterile environment within sealed packaging.
A delivery system 50 for the assembly of
The distal end of pusher tube 40 is connected to a handle 44. Release wire 32 passes through a lumen in the handle to a knob 48 which can be pulled relative to handle 44 to pull the release wire 32.
To deploy the assembly 80, it is loaded with the distal end of the tubular member 40 into the proximal end of a delivery catheter 90,
With the assembly 80 at the distal end of delivery catheter 90, and with the distal end of catheter 90 at the desired deployment site in the patient's vasculature, the medical device 10 is then advanced beyond the distal end of the sheath catheter 90 by retracting the sheath, or by pushing the deployment device 16 with pusher tube 40, or by a combination of both actions, see
Until this point in the procedure, means (not shown) are provided for holding handle 82 and knob 48 in a relatively fixed relationship. When the medical device 10 has completely left the catheter 90 and is in its final position, knob 48 is then pulled. This pulls the release wire 32 which, due to the flexible nature of wire coil 36, pulls the proximal end of the coil slightly radially inwardly and then axially in the proximal direction. As pulling on knob 48 and wire 32 continues, the wire coil 36 completely unwinds from wire 18 and then from wire 12, see
Part or all of the deployment system 50 can then be removed and another set of releasing members can be loaded into the system for successive deployment.
An advantage of the above-described arrangement is that the medical device 10 and the deployment device 16 can be separated by a simple operation in a carefully controlled manner. Separation of the devices does not require a long unscrewing procedure. Furthermore, the withdrawal can be undertaken without sudden movements, which might displace the medical device in an undesired manner. Moreover, reloading of the release members is a simple operation, which is advantageous when a plurality of implants, such as embolization coils, need to be deployed in succession.
The interconnection of members 10, 16 and 30 to form assembly 80 employs unidirectional rotation throughout. This is a single process and avoids undesired distortion of the members.
The wire coil 30 is preferably of a material which is softer and more deformable than the material of the wires 12 and 18.
The wire coil is preferably of a resilient material.
Preferred materials for the wire coil are nitinol or soft steel.
The release wire 32 can be of the same material as wire coil 36 and can be integral therewith or fixedly attached thereto. Alternatively, wire 32 can be of a different material from coil 36.
The wires 12, 18 can be of the same material as their respective devices 10, 16 and can be integral therewith or fixedly attached thereto. Alternatively, one or both wires 12, 18 can be of a different material from their respective device.
Instead of a coil 10, the implantable device can be a stent, a stent graft, a filter, a valve or any other prosthesis. When the device is an embolization coil, it is advantageous if the wire 12 is made uniformly therewith, since after deployment it can adopt the role of contributing part of the embolization function.
Various modifications can be made to the above described arrangement. For example,
Instead of assembling members 10, 16 and 30 by a rotational screwing procedure, the flexibility of the coil material may permit a more rapid method of assembly in which the coil 36 is inserted axially into the end of the helical wires 12, 18 and then sprung radially outwardly.
If desired, the release wire 32 can pass outside of deployment device 16, in which case device 16 can be a solid rod instead of a tube. In this modification, the initial movement of the wire at the end of the coil 36 is radially outwardly rather than radially inwardly. Also, an additional sheath or catheter may need to be provided around device 16 so as to provide a lumen in which the wire 32 can be withdrawn.
As described the devices 10 and 16 are generally cylindrical with a uniform circular cross-section. However, the or each device may be wholly or partly of a tapering configuration, either towards or away from the wire coil 36. In this case the wires 12 and/or 18 have a corresponding spiral or partly spiral configuration.
The cross-section of the wires 12, 18 and 36 is preferably circular, but may be elliptical, square or any other desired shape.
Whereas the wire forming the coil 130 of
In a further embodiment, shown in
In a modification of the embodiment of
Instead of a rigid sleeve 34, the assembly 80 may be provided in a relatively flexible protection sheath, which a user peels off the assembly before deployment.
The features of the various embodiments described above and their modifications may be substituted for or combined with one another as desired.
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Apr 16 2012 | BODEWADT, TUE THUREN | William Cook Europe ApS | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 029992 | /0944 | |
Apr 16 2012 | William Cook Europe ApS | Cook Medical Technologies LLC | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 029992 | /0996 | |
Mar 14 2013 | Cook Medical Technologies LLC | (assignment on the face of the patent) | / | |||
Feb 27 2024 | Cook Medical Technologies LLC | WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT | SECURITY INTEREST SEE DOCUMENT FOR DETAILS | 066700 | /0277 |
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